U.S. patent number 6,004,305 [Application Number 08/642,269] was granted by the patent office on 1999-12-21 for drainage catheter assembly.
This patent grant is currently assigned to Spectrum Medsystems, Inc.. Invention is credited to Thomas L. Hursman, Robert H. Waechter.
United States Patent |
6,004,305 |
Hursman , et al. |
December 21, 1999 |
Drainage catheter assembly
Abstract
A catheter assembly for draining and collecting fluid from a
body cavity has a container having an inner containment space
defined therewith. An elongate tubular catheter extends
longitudinally through the container. A tip member/lubricant
reservoir is mounted to the catheter passage opening. A quantity of
lubricant is disposed within a tip member/lubricant reservoir and
lubricate the catheter as it is extended from the container.
Inventors: |
Hursman; Thomas L. (Diamond
Bar, CA), Waechter; Robert H. (Scottsdale, AZ) |
Assignee: |
Spectrum Medsystems, Inc.
(Irvine, CA)
|
Family
ID: |
24575892 |
Appl.
No.: |
08/642,269 |
Filed: |
May 3, 1996 |
Current U.S.
Class: |
604/328; 600/544;
604/326; 604/349 |
Current CPC
Class: |
A61F
5/44 (20130101); A61M 25/0017 (20130101); A61M
25/002 (20130101); A61M 2025/0062 (20130101); A61M
25/007 (20130101); A61M 25/0111 (20130101); A61M
25/0068 (20130101) |
Current International
Class: |
A61F
5/44 (20060101); A61M 25/00 (20060101); A61M
25/01 (20060101); A61F 005/44 () |
Field of
Search: |
;604/264,349,352,331,326,320 ;128/761,760 |
References Cited
[Referenced By]
U.S. Patent Documents
Other References
"Dow Corning.COPYRGT. 360 Medical Fluid", Product Info. 1995 Dow
Corning Corporation (4 pages). .
"Manager Industries, Inc.", Product Designation: MP-110 Jan. 15,
1993 (2 pages). .
"Kenpak" Medical Pakaging Specialists, Kenpak Product Designation
(1 page)..
|
Primary Examiner: Bockelman; Mark
Assistant Examiner: Gring; N. Kent
Attorney, Agent or Firm: Stout, Uxa, Buyan & Mullins,
LLP
Claims
What is claimed is:
1. A catheter assembly for draining and collecting fluid from a
body cavity, said assembly comprising:
a container having an inner containment space defined therewithin,
said container having a fluid reservoir portion and a chimney
portion which extends from said fluid reservoir portion, said fluid
reservoir portion having a first width and said chimney portion
having a second width which is less than said first width;
a catheter passage opening formed in the chimney portion at a first
location;
a tip member/lubricant reservoir mounted to the catheter passage
opening, said tip member/lubricant reservoir having:
i) a hollow bore extending longitudinally therethrough, said hollow
bore having an inner surface of a diameter which is larger than the
outer diameter of the catheter;
ii) a first annular rib extending inwardly from the inner surface
of the bore of the tip member/lubricant reservoir defining a first
lubricant reservoir space distal thereof, said first annular rib
having an inner diameter which is smaller than the inner diameter
of the hollow bore, but larger than the outer diameter of the
catheter, and, a quantity of lubricant being disposed within said
first lubricant reservoir space;
said catheter being initially positioned within the inner
containment space of the container such that a portion of the
catheter extends through said chimney and into the bore of the tip
member/lubricant reservoir, the catheter being thereafter
advanceable in a distal direction through the first annular rib
such that the distal end of the catheter will become projected out
of the tip member/lubricant reservoir and a layer of lubricant will
be deposited on the outer surface of the catheter, the thickness of
said layer of lubricant being regulated by the inner diameter of
the first annular rib.
2. The catheter assembly of claim 1 wherein the tip
member/lubricant reservoir has a closed distal tip through which
the distal end of the catheter will penetrate as the catheter is
advanced in the distal direction.
3. The catheter assembly of claim 2 wherein the closed distal tip
of the tip member/lubricant reservoir has at least one slit formed
therein to permit the catheter to penetrate therethrough, said
slit(s) only partially penetrating the tip member/lubricant
reservoir, so as to prevent lubricant leakage therefrom and so as
to maintain sterility thereof prior to use.
4. The catheter assembly of claim 1 wherein the quantity of
lubricant disposed within the lubricant reservoir space of the tip
member/lubricant reservoir comprises silicone lubricant.
5. The catheter assembly of claim 4 wherein the lubricant is a
non-water-based lubricant having a shelf storage life of at least
three years.
6. The catheter assembly of claim 4 wherein the lubricant comprises
polydimethysiloxane.
7. The catheter assembly of claim 1 further comprising a second
annular rib similar to said first annular rib and formed proximally
with respect thereto, so as to define a second lubricant reservoir
space.
8. The catheter assembly of claim 7 wherein the first annular rib
member of the tip member/lubricant reservoir has an inner diameter
which is 0.5 mm larger than the outer diameter of the catheter, and
wherein said first annular rib further causes a thin film of
lubricant of 0.25 mm thickness to be deposited from said second
lubricant reservoir space onto the outer surface on the catheter as
the catheter is advanced therethrough.
9. The catheter assembly as recited in claim 1, wherein said tip
member/lubricant reservoir further comprises a third annular rib
similar to said second annular rib and formed proximally with
respect thereto, so as to define a lubricant overflow chamber
between said second annular rib and said third annular rib.
Description
FIELD OF THE INVENTION
This invention relates generally to medical devices and more
particularly to drainage catheter assemblies for draining fluid
from body cavities, such as the urinary bladder or gastrointestinal
tract.
BACKGROUND OF THE INVENTION
Various self-contained drainage catheter assemblies have been known
in the prior art. Such drainage catheter assemblies typically
comprise flexible catheters having plastic collection bags
connected thereto. The flexible catheter is insertable into a body
orifice or passageway (e.g., urethra) such that fluid may drain
through the lumen of the catheter and into the attendant collection
bag.
Examples of drainage catheter assemblies of the prior art are found
in U.S. Pat. Nos. 4,652,259 (O'Neill) and 5,147,341 (Starke et
al).
Although the self-contained drainage catheter assemblies of the
prior art have become commonly used in clinical practice,
especially for intermittent or long term catheterization of the
urinary bladder, these prior art-drainage catheter assemblies have
been of designs and configurations which are less than optimal for
all applications. Accordingly, there remains a need in the art for
the development of improved self-contained drainage catheter
assemblies which incorporate modified designs and configurations to
provide improved operability and ease of use, at least in certain
patient types and/or certain clinical situations.
SUMMARY OF THE INVENTION
The present invention comprises a catheter assembly for draining
and collecting fluid from a body cavity (e.g., the urinary bladder
or gastrointestinal tract) of a mammal. The catheter assembly
comprises a container, such as a flexible plastic bag, having an
inner fluid containment space defined therewithin. A catheter
passage opening is formed in the container or bag, at a first
location, typically at one end thereof. A tip/lubricant reservoir
member is mounted within the catheter passage opening, and is fused
or attached to the container or bag. Such tip/lubricant reservoir
has a hollow bore which extends longitudinally therethrough. An
elongate tubular catheter, having a proximal end, a distal end, an
outer surface of first outer diameter, and a hollow lumen extending
longitudinally therethrough is initially positioned within the
interior of the container or bag, with the distal end of the
catheter being inserted into the hollow bore of the tip/lubricant
reservoir. A quantity of lubricant is disposed within the sealed
tip/lubricant reservoir. Thereafter, when it is desirable to insert
the catheter into the body cavity, the catheter is advanced in the
distal direction such that it punctures the tip/lubricant
reservoir, with lubricant from the reservoir becoming deposited on
the outer surface of the catheter. In this manner, the catheter may
be inserted into the desired body cavity such that fluid from the
body cavity will drain from the lumen of the catheter, and will
become collected within the interior of the container (e.g.,
bag).
Further in accordance with the invention, an inflatable balloon or
cuff may be formed on the outer surface of the catheter, near the
distal end thereof, to retain the catheter within the urinary
bladder or other intended anatomical location. Such inflatable
balloon or cuff will enable the catheter to be utilized for long
term indwelling use and continuous drainage of a desired body
cavity.
Still further in accordance with the invention, the preferred
container comprises a pliable bag formed of plastic (e.g.,
polyethylene) film, such bag having a proximal body portion of a
first width W.sub.1, and a distal chimney portion of a reduced with
W.sub.2. The tip/lubricant reservoir is mounted within a catheter
passage opening formed in the distal end of the chimney portion of
such bag. The chimney portion of the bag may be of an angular or
tapered configuration such that its proximal base is of the reduced
width W.sub.2 and its distal end immediately adjacent the
tip/lubricant reservoir is of a further reduced with W.sub.3 which
is even smaller than the reduced width W.sub.2 at the basal end of
the chimney portion of the bag. A grasping tab may be formed at a
desired location on the chimney portion of the bag, and a
perforated or tearable line may be formed across the chimney
portion, immediately adjacent such grasping pad. In this manner,
when it is desired to empty the bag, the user may grasp the
grasping tab and may tear the chimney portion of the bag away,
thereby facilitating emptying the contents of the bag into an
appropriate container or drain. Grasping the grasping tab also
facilitates controlled manipulation of the release orifice formed
by tearing away the chimney portion, so as to facilitate easily
controlled emptying of the contents of the bag.
Still further in accordance with the invention, the tip/lubricant
reservoir member may be provided with at least a pair, preferably
three, annular internal ribs through which the catheter passes.
Such annular internal ribs will define a primary lubricant
reservoir at the distal tips of the tip/lubricant reservoir member,
a substantially cylindrical pre-lubricant reservoir space between
the two distal-most annular internal ribs and an overflow chamber
between the two proximal-most annular internal ribs. Lubricant
contained within such pre-lubrication and primary reservoirs will
become deposited upon the outer surface of the catheter as the
catheter is advanced through the annular ribs, and the distal-most
annular rib will operate to doctor or disperse the lubricant
material over the outer surface of the catheter body such that a
lubricant film of a desired thickness is evenly applied to the
entire catheter. The two proximal-most annular internal ribs, which
define the overflow chamber, mitigate overflowing of the lubricant
from the pre-lubrication reservoir to the inner fluid containment
space of the container. Frequently, it is desirable to prevent
contamination of the contents of the container, since the contents
of the container may be subject to analysis. As such, it is
important to prevent the lubricant from entering the inner fluid
containment space. Moreover, the overflow chamber defined by the
two proximal-most annular internal ribs facilitates the collection
of lubricant which leads past the second or middle annular internal
rib, so as to prevent the lubricant from entering the inner fluid
containment space of the container.
Still further in accordance with the invention, the lubricant
contained within the pre-lubrication and primary reservoirs may
comprise a silicone lubricant which resists desiccation and which
has a shelf-life in dry storage in excess of three years. In
particular, one such silicone lubricant is Dow Corning 360 Medical
Lubricant, which has a dry storage shelf-life of approximately five
years. The use of such silicone lubricant in the drainage catheter
assemblies of the present invention permits shelf-storage of the
drainage catheter assemblies for extended periods of time, such as
more than four years, in contrast to drainage catheter assemblies
of the prior art which have utilized water-based lubricant such as
K-Y jelly having shelf storage lives in dry storage conditions of
less than one year. The preferred Dow Corning 360 Medical Fluid
Lubricant used in the drainage catheter assemblies of the present
invention has a published shelf-life of sixty months when stored at
or below 25.degree. C.
Further objects and advantages of the invention will become
apparent to those skilled in the art upon reading and understanding
the following detailed description and the accompanying
drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a perspective view of a first embodiment of a drainage
catheter assembly of the present invention.
FIG. 2 is an enlarged view of one end of the drainage catheter
assembly of FIG. 1.
FIG. 3 is an enlarged view of the tip of the drainage catheter
assembly of FIG. 1.
FIG. 4 is a longitudinal section view through line 4--4 of FIG.
3.
FIG. 5 is a rear perspective view of the distal catheter tip shown
in FIG. 3.
FIG. 6 is a perspective view of the distal tip of the drainage
catheter assembly shown in FIGS. 1-5 during distally-directed
advancement of the catheter tube.
FIG. 7 is a side elevational/partially cut-away view of the
catheter tube incorporated in the drainage catheter assembly shown
in FIGS. 1-6.
FIG. 8 is a side elevational view of a second embodiment of a
drainage catheter assembly of the present invention, having an
inflatable cuff formed on the catheter tube for retaining the
catheter tip within the urinary bladder or other anatomical
structure.
FIG. 9 is a side elevational/partially cut-away view of the
catheter tube incorporated in the drainage catheter assembly of
FIG. 8.
FIG. 9a is a cross sectional view through line 9a-9a of FIG. 9.
FIG. 10 is a perspective view of a method by which the drainage
catheter assemblies shown in FIGS. 1-9 may be folded to facilitate
packaging thereof.
FIG. 10a is a partial perspective view of a preferred packaging
envelope of the present invention containing a drainage catheter
assembly of the present invention folded in the manner shown in
FIG. 10.
FIG. 10b is a partial elevational view showing a packaging envelope
of the present invention containing a drainage catheter assembly of
the first embodiment, folded in the manner shown in FIG. 10.
FIG. 10c is a partial elevational view showing a packaging envelope
of the present invention containing a drainage catheter assembly of
the second embodiment, folded in the manner shown in FIG. 10.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
The following detailed description and the accompanying drawings
are provided for the purpose of describing and illustrating
presently preferred embodiments of the invention only, and are not
intended to limit the scope of the invention in any way.
First Embodiment
FIGS. 1-7 show a first embodiment of a drainage catheter assembly
10 of the present invention.
The drainage catheter assembly 10 comprises an elongate tubular
catheter 12 and a pliable plastic containment bag 14. The elongate
tubular catheter 12 is initially disposed within the interior of
the containment bag 14, and is subsequently advanceable in the
distal direction DE to facilitate insertion of the catheter into a
body passageway. For example, the catheter tube 12 may be inserted
into the nose and downwardly through the esophagus to accomplish
naso-gastric intubation. Similarly, the distal portion of the
catheter tube 12 may be advanced into the urethra of a male or
female patient to accomplish catheterization and drainage of urine
from the urinary bladder.
The elongate tubular catheter 12 is of a first outer diameter
D.sub.1. A catheter retaining apparatus, such as a proximal
engagement member 16 is formed on the tubular catheter 12 to
prevent the catheter 12 from being fully extracted from, and
separated from, the collection bag 14. The proximal engagement
member 16 has an outer diameter D.sub.2 which is larger than the
outer diameter D.sub.1 of the elongate tubular catheter body 12. A
tapered shoulder 18 is formed on the forward or distal edge of the
proximal engagement member 16. When the elongate catheter 12 is
fully advanced in the distal direction, out of the containment bag
14, the annular shoulder 18 of the proximal engagement member 16
will abut against the proximal end of a stationary tip/lubricant
reservoir 20 formed on the distal end of the chimney portion 22 of
the containment bag 14. Such abutment of the proximal abutment
member 16 against the stationary tip/lubricant reservoir 20 serves
to prevent the tubular catheter 12 from being fully extracted and
removed from the bag 14. In this regard, when the catheter 12 is
fully advanced in its distal direction and inserted into a body
passageway of a patient, body fluids which are drained through the
lumen 13 of the catheter 12 will become collected in the collection
bag 14.
The tubular catheter 12 has a blunt tapered or blunt-conical distal
tip 24. A plurality of apertures 26 are formed in the sidewall of
the catheter 12, near its distal tip 14, to permit body fluid
and/or other matter to drain into the lumen 13 of the catheter
12.
The tip/lubricant reservoir 20 is configured and constructed to
facilitate firm sealing of the chimney portion 22 of containment
bag 14 thereto, and to provide for even and continuous deposition
of lubricant upon the outer surface of the catheter 12 as the
catheter is advanced in the distal direction. The preferred design
and construction of the tip/lubricant reservoir 20 is shown in
FIGS. 4-6. As shown, the tip/lubricant reservoir 20 has a hollow
inner bore or catheter passageway 30 extending longitudinally
therethrough. A closed distal tip 32, is formed on the distal end
of the hollow bore 30 and is provided with one or more catheter
penetrable openings 34, such as self-sealing slit(s) or disruptable
perforations, to permit the blunt distal tip 24 of the catheter 12
to penetrate through the distal tip 32 of the tip/lubricant
reservoir 20. In the preferred embodiment shown, two (2) crossed
slits 34 are partially pre-cut in elastomeric material of the
distal tip 32, as shown. Such partial cuts do not extend through
the full thickness of the tip 32, but rather penetrate only
sufficiently to allow easy puncturing by the distal tip 24 of the
catheter 12.
Use of such a partially pre-cut or perforated distal tip 32 allows
maintenance of the catheter in a sterile condition right up until
the time immediately prior to which the catheter is forced
therethrough. In this manner, the catheter creates a passageway
through the distal tip 32 immediately prior to use. By way of
contrast, contemporary catheters commonly allow undesirable
non-sterile touching or atmospheric contact with the distal end of
the catheter.
As shown in FIG. 4, the thickness of the material of which the
tip/lubricant reservoir 20 is formed may be lessened or diminished
in the region of distal tip 32 to facilitate such penetration of
the distal catheter tip 24 therethrough. An annular flange 60 is
preferably formed about the tip/lubricant reservoir 20, as
shown.
The individual components of the catheter assembly 10 may be formed
of any suitable materials. In the presently preferred embodiments
shown in the drawings, the containment bag 14 may be formed of low
density polyethylene film having a thickness of approximately 0.003
inch such as that sold under the trademark PETROTHENE PE 4955 B
available commercially from Quantum Chemical Corporation, Rolling
Meadows, Ill. The catheter 12 may be formed of polyvinyl chloride
tubing such as that commercially available from Kelcourt Plastics,
Inc., San Clemente, Calif. The tip member/lubricant reservoir 20
may be formed of a pliable silicone material. The lubricant
contained within the tip member/lubricant reservoir is preferably
polydimethysiloxane fluid, such as DOW CORNING 360 Medical Fluid
available commercially from Dow Corning Corporation, Midland,
Mich., preferably having a viscosity at 25.degree. C. of
approximately 350 centistokes.
The inner bore 30 of the tip/lubricant reservoir 20 has a diameter
D.sub.3 which is larger than the outer diameter D.sub.1 of the
catheter 12. First, second and third annular rib members 36, 38,
38' are formed around the inner surface of the longitudinal bore 30
of the tip/lubricant reservoir 20, at spaced-apart locations as
shown in FIG. 4. The innermost surfaces of these annular rib
members 36, 38, 38' are smaller than the inner diameter D.sub.3 of
the inner bore 30 but still slightly larger than the outer diameter
D.sub.1 of the catheter 12. In this manner, the annular rib members
36, 38, 38' abut against or are close-spaced away from the outer
surface of the catheter 12 as the catheter is longitudinally
advanced through the bore 30 of the tip/lubricant reservoir 20.
A primary lubricant reservoir 39 is defined within the distal-most
portion of the inner bore 30 between the tip 32 and the first
annular rib member 36. A pre-lubrication reservoir is formed within
the bore 30 between the first annular rib member 36 and the second
annular rib member 38. In a similar fashion, a lubricant overflow
reservoir is defined within the bore 30 between the second annular
rib member 38 and the third annular rib member 38'. A lubricant
overflow reservoir is defined between annular rib members 38 and
38'. A quantity of flowable lubricant is initially deposited within
the cylindrical lubricant space 40 at the time of fabrication or
manufacture of the catheter assembly 10. Thereafter, when the
pliable catheter 12 is advanced in the distal direction, the blunt
distal tip 24 of the catheter 12 will penetrate through the
catheter-penetrable distal tip 32 of the tip/lubricant reservoir
30, and further such that the lubricant material contained within
the cylindrical lubricant space 40 becomes evenly distributed in a
thin film upon the advancing outer surface of the catheter 12.
The apertures 26 are preferably formed within the tubular catheter
12 such that they are proximal of annular rib member 38, so as to
prevent plugging of the apertures 26 with lubricant.
The outer surface of the tip/lubricant reservoir 20 incorporates an
annular enlargement 44 which serves to promote fusion or sealing of
the material of the collection bag 14 to the neck of the
tip/lubricant reservoir 20. In this regard, the top edge of the
chimney portion 22 of the collection bag 14 is positioned
immediately forward of the annular enlargement or ring 44 and the
material of the bag is laminated, heat fused, adhered, or otherwise
affixed to the outer surface of the annular enlargement 44, as
shown in FIGS. 4 & 5. In this manner, the annular enlargement
44 formed on the outer surface of the distal tip member/lubricant
reservoir 20 forms a fusion zone whereupon the material of the
collection bag 14 may be firmly fused and/or otherwise affixed to
the neck of the distal tip member/lubricant reservoir 20. In this
manner, the distal tip member/lubricant reservoir 20 is
stationarally affixed to the opening formed at the top end of the
chimney portion 22 of the collection bag 14.
It will be appreciated that the containment bag 14 may be of any
suitable size and shape. In the preferred embodiment shown in the
drawings, the containment bag 14 has a lower portion of a first
width W.sub.1, and an upper chimney portion 22 which, at its basal
end, has a width W.sub.2 which is approximately one half of the
full width W.sub.1 of the lower portion of the bag. The chimney
portion 22 preferably tapers to a distal end width W.sub.3 which is
only slightly wider than the diameter of the annular flange 60
formed on the tip member/lubricant reservoir 20.
A graspable tear tab 62 is formed on one side of the chimney
portion 22 of the bag 14, immediately below a traversing
perforation 64. The traversing perforation 64 forms a weakened line
across the chimney 22 of the bag 14 such that, when it is desired
to obtain a sample of the fluid collected within the bag 14, the
user may grasp the tear tab 62, and tear the chimney 22 of the bag
14 across the perforated tear line 64, thereby detaching the
distal-most portion of the chimney 22 of the bag, and providing an
opening through which a sample of fluid contained in the bag may be
decanted or poured.
The perforations 64 only partially penetrate the thickness of the
bag 14, such that they make tearing therealong easy, but do not
cause undesirable leakage from the bag 14 prior to such
tearing.
The tear tab 62 and perforations 64 thus facilitate emptying of the
bag 14. Such emptying of the bag may be useful when a sample of the
fluid contained therein is desired. Accurate control of the fluid
being so emptied from the bag 14 is facilitated by the chimney 22
which may be grasped therearound by the human hand, so as to
restrict the flow of fluid from the bag 14, as desired. Thus, the
chimney portion 22 of the bag 14 defines a neck or spout which may
be grasped by the user's hand and squeezed so as to provide for
controlled dispensing of the fluid contained within the bag 14.
Second Embodiment
FIGS. 8, 9, 9a and 10c show a second embodiment of the catheter
assembly 10a. This second embodiment of the catheter assembly 10a
comprises a catheter 12a, collection bag 14a and distal tip
member/lubricant reservoir 20a which are the same as described
hereabove with respect to the first embodiment of the catheter
assembly 10. However, this second embodiment of the catheter
assembly 10a further incorporates an annular inflatable balloon 50
mounted upon the outer surface of the catheter 12 at a spaced
distance X from the distal tip of the catheter 12a. A balloon
inflation lumen 52 is formed within the body of the catheter 12a,
and a balloon inflation tube 54 extends from the proximal end of
the catheter 12a to permit infusion/withdrawal of inflation fluid
into/out of the balloon 50.
The balloon inflation lumen 52 may be formed by any suitable means.
For example, the balloon inflation lumen 52 may comprise a separate
tube which extends longitudinally through the lumen 13a of the
catheter 12a. Alternatively, in the embodiment shown in FIGS. 9-9a,
the balloon inflation lumen 52 comprises a partitioned off segment
of the main catheter lumen 13a, and is defined by a bulkhead member
61 which extends longitudinally through the catheter body 12a so as
to divide the main catheter drainage lumen 13a from the balloon
inflation lumen 52.
An inflation fluid port 63 is formed in the catheter body 12a
between the balloon inflation lumen 52 and the interior of the
balloon 50. In this regard, balloon inflation fluid may be passed
distally through the balloon inflation lumen 52 and outwardly
through the balloon inflation fluid port 63 to facilitate inflation
of the balloon 50. Thereafter, such balloon inflation fluid may be
withdrawn inwardly through the inflation fluid port 63 and in the
proximal direction out of the inflation fluid lumen 52.
To facilitate the infusion/withdrawal of balloon inflation fluid, a
pliable balloon inflation tube 54 is fused, heat-sealed, adhered or
otherwise attached to the proximal end of the balloon inflation
lumen 52. A pressure-distensible inflation indicator sac 56 is
mounted on the proximal end of the balloon inflation tube 54 and a
connector 58, such as a valved Luer connector, is incorporated into
or connected to such inflation fluid sac 56. In this manner, a
syringe may be attached to the connector 58, and a balloon
inflation fluid (e.g., air, saline solution, etc.) may be infused
from the syringe, through the connector 58, through the inflation
fluid tube 54, through the inflation fluid lumen 52, out of the
inflation fluid port 63 and into the balloon 50. When sufficient
inflation pressure is reached within the interior of the balloon
50, the inflation indicator sac 56 will be distended and visibly
filled with inflation fluid. On the other hand, when insufficient
inflation pressure is contained within the balloon 50 the indicator
sac 56 will be visibly flaccid or deflated. In this manner, the
inflation fluid indicator sac 56 will serve as a visual indicator
of the inflation status of the balloon 50.
When it is desired to deflate the balloon, the plunger of the
syringe attached to the connector 58 will be withdrawn, thereby
drawing inflation fluid in the proximal direction from the balloon
50, throughout inflation fluid port 63, in the proximal direction
through inflation fluid lumen 52 and inflation fluid tube 54, and
the connector 58. When the balloon has reached its fully deflated
condition, the inflation indicator sac 56 will be flaccid and
deflated, thereby serving as a visual indicator that the balloon 50
has been fully deflated.
The connector 58 may incorporate a check valve or valving apparatus
of the type well known in the art to permit fluid to be infused and
withdrawn through tube 54 so long as a syringe is attached to the
connector be fitted with an external stop cock or other suitable
type of closure apparatus such that, when the syringe is detached
from the valve Luer connector 58, the Luer connector 58 will
close-off thereby preventing inadvertent leakage of fluid out of
the balloon 50.
Manufacturing of the Catheter Assembly
The preferred catheter assemblies 10, 10a of the present invention,
as described hereabove, may be manufactured by any suitable means.
In the preferred embodiments shown, the containment bag 14, 14a is
initially formed from a tube formed of polyethylene film having a
thickness of approximately 0.003 inch and a width W.sub.1. The
outline of the tapered chimney portion 22, 22a and graspable tab
member 62, 62a are then cut out of such polyethylene film tube. The
tip/lubricant reservoir 20 is then inserted to its desired position
and a heat lamination process is utilized to form the peripheral
lamination 66 (e.g, heat seal) around the outer edges of the
chimney portion 22, 22a and grasping tap 62, 62a, as shown. A
perforation tool may then be used to form the partially perforated
tear line 64, 64a diagonally across the chimney portion 22, 22a of
the containment bag 14, 14a, preferably in alignment with the
diagonal distal edge of the grasping tab 62, 62a, as shown. The
perforation tear line 64, 64a may be formed by either forming a
series of perforations or forming a single continuous cut. In
either case, the perforations or cut are formed such that they do
not completely penetrate the wall of the bag 14, 14a, so as to
prevent undesirable leakage of fluid from the bag 14, 14a.
It will be appreciated, that the heat lamination process utilized
to form the peripheral lamination 66, 66a about the outer edge of
the chimney portion 22, 22a of the bag 14, 14a will also securely
fuse the distal end of the chimney portion 22, 22a to the annular
enlargement 44 formed on the tip/lubricant reservoir 20, 20a. In
this manner, the tip/lubricant reservoir 20, 20a will be firmly
affixed to the distal end of the containment bag 14, 14a with the
annular flange 60, 60a of the tip/lubricant reservoir 20, 20a being
adjacent the distal end of the chimney portion 22, 22a of the bag
14, 14a.
The catheter 12, 12a is then inserted into the interior of the
containment bag 14, 14a and the distal end of the catheter is
advanced into the tip/lubricant reservoir 20, 20a such that the
blunt distal tip 24, 24a of the catheter is distal to the first or
distal-most annular rib 36 formed within the tip/lubricant
reservoir 20, 20a. Thereafter, a proximal lamination 68, 68a (e.g.,
heat seal) is formed across the proximal portion of the containment
bag 14, 14a, immediately behind the proximal end of the catheter
12, 12a. This proximal lamination 68, 68a serves to prevent the
catheter 12, 12a from retracting in the proximal direction such
that the distal tip 24, 24a of the catheter 12, 12a could escape
from its intended position wherein the body of the catheter
protrudes past the first annular rib 36 of the tip/lubricant
reservoir 20. In this manner, the desired longitudinal positioning
of the catheter 12, 12a is maintained, with the distal end of the
catheter being resident within the bore 30 of the distal tip member
20, 20a during packaging and shipment of the catheter assembly 10,
10a.
According to the preferred embodiment of the present invention, the
lubricant, preferably a silicone lubricant such as
polydimethysiloxane (e.g., DOW CORNING 360 Medical Fluid, The Dow
Chemical Company, Midland, Mich.) is deposited within the primary
reservoir 39 prior to advancing the catheter 12, 12a into the
tip/lubricant reservoir 20, 20a. Additional lubricant, again
preferably a silicone lubricant such as DOW CORNING 360 Medical
Fluid, is subsequently added to the pre-lubrication reservoir 40
utilizing a syringe. Those skilled in the art will appreciate that
various other means for dispensing lubricant into the primary 39
and pre-lubrication 40 reservoirs are likewise suitable.
The preferred method of packaging the catheter assembly 10, 10a, is
by initially folding the containment bag 14, 14a along an imaginary
fold line FL which projects longitudinally down the approximate
longitudinal midpoint of the proximal portion of the containment
bag 14, 14a, as shown in FIG. 10. Thereafter, the folded catheter
assembly 10, 10a is inserted into a pouch comprised of spunbonded
polyolefin (uncoated) such as 1059 B Tyvek, Manufactured by Mangar
Industries, Inc. of New Britain, Pa., preferably having a thickness
of approximately 0.0067 inch, defining a base card or sheet 70, and
a preferably transparent top sheet 72, preferably comprised of a
material such as 0.0048 inch polyester/0.002 low density
polyethylene, such as NP-110, manufactured by Mangar Industries,
Inc. of New Britain, Pa. The top sheet 72 is fused, about its
periphery, to the base sheet 70 such that a peripheral lamination
or seal 74 is formed therearound. In this manner, the catheter
assembly 10, 10a is securely enclosed within an envelope or blister
pack which is substantially impervious to contaminants or
microbiological pathogens.
Use and Operation of the Preferred Catheter Assemblies
In routine operation, the catheter assembly 10, 10a will be removed
from its package, and the urethral meatus of the patient will be
cleansed utilizing an appropriate antiseptic solution. The person
inserting the catheter will then grasp the catheter assembly 10,
10a proximal to the annular flange 60, 60a of the tip/lubricant
reservoir 20, 20a, and will position the closed distal tip 32 of
the tip/lubricant reservoir 20, 20a immediately adjacent the
urethral meatus of patient.
Thereafter, the catheter 12, 12a will be grasped through the
containment bag 14, 14a and will be advanced in the distal
direction such that the distal tip 24 of the catheter 12, 12a
passes through the partially formed slits 34 at the distal tip 32
of the tip/lubricant reservoir 20, 20a and into the urethra of the
patient. Thereafter, the catheter 12, 12a is further advanced,
approximately 2 inches at a time, until the apertures 26 formed in
the side wall of the catheter 12, 12a are positioned within bladder
of the patient, and urine begins to flow through the lumen 13, 13a
of the catheter and into the containment bag 14, 14a. As the
catheter 12, 12a is advanced through tip/lubricant reservoir 20,
20a, lubricant is first applied thereto from the pre-lubrication
reservoir 40 and then further lubricant is applied thereto from the
primary lubricant reservoir 39, so as to assure a generally even
and adequate quantity of lubrication is applied thereto.
Thereafter, the bag may be retracted until the proximal engagement
member 16, 16a formed on the proximal end of the catheter 12, 12a
engages or abuts against the proximal end of the distal
tip/lubricant reservoir 20, 20a, and the bag 14, 14a may be
attached to an appropriate hanging apparatus such that urine flow
may continue to collect within the bag 14, 14a.
It will be appreciated that, as mentioned above, as the catheter
12, 12a is advanced into the urethra of the patient, lubricant
contained within both the pre-lubrication reservoir 40 and the
primary lubricant reservoir 39 will become deposited on the outer
surface of the catheter, 12, 12a and will serve to assure adequate
lubrication of the catheter.
When the catheter is intended to remain indwelling for a period of
time, the second embodiment of the invention shown in FIGS. 8-9
will typically be utilized. When such second embodiment of the
catheter assembly 10a is utilized, a syringe will be connected to
the balloon fluid infusion port 58 and will be utilized to inflate
the balloon 50 while it is located within the patient's bladder.
When so inflated, the balloon 50 will be prevented from being
retracted out of the bladder, and the catheter 12a will thus remain
indwelling within the bladder for the desired period of time.
Thereafter when it is desired to remove the catheter, a syringe
will again be attached to the balloon fluid inflation port 58 and
will be utilized to withdraw the inflation fluid from the balloon,
thereby deflating the balloon and permitting the catheter 12a to be
withdrawn from the patient.
In either embodiment of the invention, the bag 14, 14a may be
emptied by grasping the grasping tab 62, 60a and tearing the
chimney 22, 22a of the bag away at the perforated tear line 64,
64a. Thereafter, the torn-away chimney portion 22, 22a of the bag
14, 14a with the catheter 12, 12a attached thereto may be
discarded, and the remaining proximal portion of the bag may be
emptied, or aliquot of urine may be decanted into sample containers
for subsequent laboratory analysis or retention.
It will be appreciated that the invention has been described
hereabove with reference to certain presently preferred embodiments
only, and no effort has been made to exhaustively describe all
possible embodiments in which the invention may take form. Indeed,
various additions, deletions, modifications and alternations may be
made to the above-described embodiments without departing from the
intended spirit and scope of the invention. Accordingly, it is
intended that all such additions, deletions, alterations and
modifications be included within the scope of the following
claims.
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